Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

Wyeth is now a wholly owned subsidiary of Pfizer80 enrolled

Overview

Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

bapineuzumabDRUG

The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.

bapineuzumabDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of AD * Age 50-85 * MMSE 14-26 * Other Inclusion Criteria Apply Exclusion Criteria: * Significant Neurological Disease * Major Psychiatric Disorder * Clinically Significant Systemic Illness * Other Exclusion Criteria Apply

Locations (4)

Pfizer Investigational Site

Chiba, Japan

Pfizer Investigational Site

Saitama, Japan

Pfizer Investigational Site

Shizuoka, Japan

Pfizer Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between dose of study medication and up to 52 weeks after the dose that were absent before treatment or that worsened relative to pre-treatment state.

Time frame: Baseline up to Week 52

Number of Participants With Clinically Significant Changes in Physical Examinations

Physical examination included the assessment of abdomen, back/spinal, breasts, external genitalia, extremities, general appearance, head, eyes, ears, nose, throat (HEENT), heart, lungs, lymph nodes and skin.

Time frame: Screening up to Week 52

Number of Participants With Vital Signs of Potential Clinical Importance

Criteria for determining potentially clinically important (PCI) vital signs was described as: supine blood pressure (BP)- systolic (greater than or equal to \[\>=\]160 millimeter mercury \[mm Hg\] or less than or equal to \[\<=\]90 mm Hg and increase or decrease of \>=20 mm Hg compared to baseline value), supine diastolic BP (\>=100 mm Hg or \<= 50 mm Hg and increase or decrease of \>=15 mm Hg compared to baseline value), supine pulse rate (\>=120 beats per minute (bpm) or \<=45 bpm and increase or decrease of \>15 bpm compared to baseline value), body temperature (\>38.3 degree Celsius and \<35 degree Celsius).

Time frame: Baseline up to Week 52

Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance

Criteria for determining PCI ECG result was described as: heart rate (\>=120 bpm or \<=45 bpm and increase or decrease of \>15 bpm compared to baseline value), PR interval (\>=220 millisecond (msec) and change of \>=20 msec compared to baseline value), QRS interval (\>=120 msec), corrected QT (QTc) interval for men (\>450 msec), QTc interval for women (\>470 msec).

Data from ClinicalTrials.gov

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Number of Participants With Laboratory Test Results of Potential Clinical Importance

Criteria for PCI laboratory results: hematology (hematocrit \[decrease \>=5%\], hemoglobin \[decrease \>=20gram/liter {g/L}\] from baseline, white blood cells \[\<3\], neutrophils \[\<1.5\], platelet \[\<100\], eosinophils \[\>0.5\] \*10\^9/L); blood chemistry (sodium \[\>5\], potassium \[\>0.5\], fasting glucose \[\>0.83\], phosphorous \[\>0.162\] millimole/L \[mmol/L\] above upper limit of normal \[ULN\] and below lower limit of normal \[LLN\], non-fasting glucose \>5 mmol/L above ULN, \>0.56 mmol/L below LLN, creatinine \>1.36\*ULN, blood urea nitrogen \>1.5\*ULN, calcium \[change of \>=0.25 mmol/L\], total protein \[change of \>=20g/L\], albumin \[change of \>=10g/L\], uric acid \[change of \>0.119mmol/L\] from baseline and outside normal limits); Liver function tests (alanine aminotransferase/serum glutamic pyruvic transaminase \[ALT/SGPT\] and aspartate aminotransferase/serum glutamic oxaloacetic transaminase \[AST/SGOT\] \>2\*ULN, total bilirubin \>2\*ULN, alkaline phosphatase \>1.5\*ULN, gamma-glutamyl-transpeptidase \[GGT\] \>3\*ULN).

Time frame: Week 1 up to Week 52